Does Routine Assessment of Gastric Residuals in Preterm Neonates Influence Time Taken to Reach Full Enteral Feeding? (GRASS)

A Prospective, Randomized and Controlled Trial Comparing the Role of no Gastric Residual ASSessment and Standard Gastric Residual Measurement for the Achievement of Full Enteral Feeding in Preterm Infants

The study aims to compare routine assessment of gastric residuals versus no assessment of residuals in preterm neonates with respect to time taken for achieving full enteral feeding and the incidence of possible complications, such as feeding intolerance, necrotizing enterocolitis, sepsis etc.

Study Overview

• Status: Unknown
• Conditions: Prematurity; Necrotizing Enterocolitis of Newborn; Sepsis Newborn; Gastric Residuals Assessment
• Intervention / Treatment: Other: No aspiration of gastric residuals

Detailed Description

In general, regular assessment of gastric residuals and its´ evaluation prior to every feeding is considered standard practice for preterm neonates in neonatal intensive care units. It is believed useful to confirm correct placement of the orogastric or nasogastric tube and thought of as necessary to aid the decision of enteral feeding advancement by informing about possible remains of contents from previous feeding. Furthermore, evaluation of gastric residuals is routinely performed in order to assess for feeding intolerance and used as a possible indicator of risk for development of necrotizing enterocolitis.

However there is conflicting evidence to support the approach of routine gastric residuals assessment and it seems unclear whether it confers any clinical benefit. Withholding of enteral feeding or cessation of advancement in the amounts given due to misinterpretation of routine gastric aspirates may have a negative impact on the preterm neonate. This can potentially involve prolonged indwelling of venous catheters, higher risk of infection and growth restriction with potentially worse developmental outcome in particular for very low birth weight infants.

This randomized controlled clinical study aims to compare a control group with regular assessment and evaluation of gastric residuals and an intervention group with no routine assessment of residuals prior to feeding advancement, for the time taken to reach full enteral feeding and for occurrence of any observed complications including necrotizing enterocolitis.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zbynek Stranak, Ass. Prof.; Phone Number: +420296511806; Email: zbynek.stranak@upmd.eu
• Study Contact Backup: Name: Simona Feyereislova, MD; Phone Number: +420296511807; Email: simona.feyereislova@upmd.eu

Study Locations

• Czechia
  • Prague, Czechia
    • Recruiting
    • Institute for the Care of Mother and Child
    • Contact: Simona Feyereislova, MD; Phone Number: +420296511807; Email: simona.feyereislova@upmd.eu
    • Principal Investigator: Simona Feyereislova, MD
    • Sub-Investigator: Ivan Berka, MD
• Ireland
  • Dublin, Ireland
    • Not yet recruiting
    • Coombe Women and Infants University Hospital
    • Contact: Jan Miletin, MD; Phone Number: 087 7386379
    • Principal Investigator: Jan Miletin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 6 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Preterm neonate, born between 26+0 and 30+0 weeks of gestation
• Birth weight below 1500g
• Parental informed consent obtained

Exclusion Criteria:

• Intrauterine growth retardation (birth weight below 5th centile for given gestational age and gender)
• Life-threatening events requiring full resuscitation at the delivery room (severe hypoxia, bleeding), and persistently raised lactate value of more than 5 mmol/l
• Circulatory instability requiring treatment with inotropes
• Highly suspected early onset sepsis with alteration of general clinical state, in particular with worsened peripheral perfusion and circulatory decompensation prior to study begin (during the first 6 hours after admission to NICU)
• Known malformations of gastrointestinal tract, known diagnosis of congenital diaphragmatic hernia, any other life-limiting serious congenital malformations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GRASS - Intervention group; The intervention group (GRASS) will receive 3 hourly feeds, with no gastric residuals being aspirated. Solely opening of the nasogastric tube once every 6 hours to relieve possible backflow of gastric content will be allowed. Amount of enteral feeds given and increase in dose will be specified in an enteral feeding plan prior to start of the study. Amount of enteral feeds given will increase every six hours with a calculated overall increase of 20 ml/kg of birth weight in the total amount given every 24 hours. Intervention = NO aspiration of gastric residuals	Other: No aspiration of gastric residuals; No assessment of gastric residuals will be performed prior to administering 3-hourly feeds with increasing amounts of the feeds given as per a predefined plan
No Intervention: Standard Approach group; Standard Approach group serving as control group will be treated as per standard approach - participants will be fed 3 hourly and gastric residuals checked via nasogastric tube prior to each feed. Amount of enteral feeds given and increase in dose will be specified in an enteral feeding plan prior to start of the study. Amount of enteral feeds given will increase every six hours with a calculated overall increase of 20 ml/kg of birth weight in the total amount given every 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days taken to achieve full enteral feeding (i.e. dose of 100ml/kg/day)	Time taken (in hours) to reach full enteral feeding, defined as overall dose of 100ml of feeds/kg of birth weight/ day	5 days after delivery for yes or no answer to whether full enteral feeding has been achieved, thereafter daily for the first three weeks until full enteral feeding has been reached

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Withholding of enteral feeding	The need to withhold enteral feeds due to clinical situation as per clinical judgement of the clinician in charge	Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Total duration of parenteral infusion	The length of time (in hours) that parenteral infusion is needed	Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Total duration of indwelling central venous catheter	The length of time (in hours) that an indwelling central venous catheter is needed	Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Hypoglycaemia	Any episodes of hypoglycaemia (value less than 2,5 mmol/l) after attainment of full enteral feeding	Through first (on average) two to three weeks of the study until full enteral feeding is achieved.
Late onset sepsis	The incidence of late onset sepsis	Duration of hospitalization, an average of 8-15 weeks
Necrotizing enterocolitis	The incidence of necrotizing enterocolitis	Duration of hospitalization, an average of 8-15 weeks
Spontaneous intestinal perforation	The incidence of spontaneous intestinal perforation	Duration of hospitalization, an average of 8-15 weeks
Bronchopulmonary dysplasia	Incidence of bronchopulmonary dysplasia	At timepoint of reached 36 gestational weeks of the neonate
Intraventricular and periventricular haemorrhage	The incidence of intraventricular and periventricular haemorrhage (stage I-IV)	Duration of hospitalization, an average of 8-15 weeks
Retinopathy of prematurity	Incidence of retinopathy of prematurity (stage I-V)	Duration of hospitalization, an average of 8-15 weeks
Neurodevelopment	Assessment of neurodevelopmental outcome	Follow up at 24 months of corrected age of the child

Collaborators and Investigators

• Sponsor: Institute for the Care of Mother and Child, Prague, Czech Republic
• Collaborators: Coombe Women and Infants University Hospital
• Investigators: Study Chair: Zbynek Stranak, MD, Institute for the Care of Mother and Child in Prague

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2017
• Primary Completion (Anticipated): December 30, 2019
• Study Completion (Anticipated): December 30, 2019

Study Registration Dates

• First Submitted: March 23, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): November 20, 2018
• Last Update Submitted That Met QC Criteria: November 19, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Prematurity; Gastric residuals assessment; Necrotizing Enterocolitis of Newborn; Sepsis Newborn; Nutrition of newborn; feeding tolerance of newborn
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Gastrointestinal Diseases; Infant, Newborn, Diseases; Gastroenteritis; Intestinal Diseases; Sepsis; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth; Enterocolitis; Enterocolitis, Necrotizing; Neonatal Sepsis
• Other Study ID Numbers: GRASS-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Available on request after publication of study results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No